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Staying Connected: Trauma Center to Tribal Community Linkage for Physically Injured American Indian Patients

19 juni 2012 bijgewerkt door: Douglas Zatzick, University of Washington

American Indian and Alaska Native Health Disparities Staying Connected: Trauma Center to Tribal Community Linkage for Physically Injured American Indian Patients

The purpose of this study is to provide American Indian trauma patients, treated at the Harborview Level 1 urban trauma center, compassionate and culturally sensitive care and to link them to care in their distant tribal communities. The specific aims include 1) interview Native healers to gather information on culture-specific aspects of recovery from traumatic injury and on linking care to tribal communities, 2) conduct a randomized controlled trial to evaluate the implementation and effectiveness of the intervention. The investigators hypothesize that intervention patients will demonstrate greater improvement than controls in post-traumatic stress disorder (PTSD) symptoms, depression, functioning, diagnoses, and fewer new injuries during the 6 months after the index injury.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

American Indians are at a greater risk for traumatic life events than the general population and compared to Whites they have a 2.04 (95% CI 1.11, 3.54) fold increased risk of Post Traumatic Stress Disorder (PTSD) symptoms. Among more than 2,900 injured trauma survivors treated at 69 hospitals nationwide, American Indians had the highest risk of all racial/ethnic groups of developing symptoms consistent with a diagnosis of PTSD 12 months after injury. Similarly, among 269 traumatically injured patients hospitalized at 2 level 1 trauma centers in the Western U.S., PTSD and peritraumatic dissociative symptoms were significantly more frequent among American Indians compared to Whites.

Nine percent of 6,000 injured trauma survivors admitted annually to the Harborview Level 1 trauma center are American Indian. Approximately 40 percent of these patients live more than 50 miles from the trauma center, including tribal communities in Eastern Washington and the Olympic Peninsula. Through prior work, researchers have found that care management interventions can reduce PTSD symptoms among diverse injured urban patients. Investigators from the Center of Excellence suggest that American Indian trauma survivors may have unique culture-specific idioms for posttraumatic distress (e.g. "wounded spirit"), and that trauma interventions with indigenous approaches may be productively applied to patients suffering from posttraumatic distress.(5)

In an effort to reduce the risk of PTSD and other general symptoms of trauma among American Indians, we plan to conduct a pilot study to develop and evaluate an American Indian culture specific care management intervention, Staying Connected.

Based on the Trauma Survivors and Support Study (TSOS), the purpose of Staying Connected is to provide American Indian trauma patients, treated at the Harborview Level 1 urban trauma center, compassionate and culturally sensitive care and to link them to care in their distant tribal communities. The specific aims include 1) interview Native healers to gather information on culture-specific aspects of recovery from traumatic injury and on linking care to tribal communities, 2) conduct a randomized controlled trial to evaluate the implementation and effectiveness of the intervention. We hypothesize that intervention patients will demonstrate greater improvement than controls in PTSD symptoms, depression, functioning, diagnoses, and fewer new injuries during the 6 months after the index injury.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Harborview Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Harborview trauma patient 18 years or older
  2. self identify as American Indian or Alaska Native
  3. speak English

Exclusion Criteria:

  1. non-American Indian or Alaska Native status reported
  2. monolingual non-English speaking status
  3. age < 18 years
  4. old head, spinal cord or other injuries that prevent participation in the interview
  5. any self-inflicted injury, active psychosis, mania, and victims of intimate partner violence who require immediate intervention
  6. currently incarcerated patients or a recent history of severe violence which will likely yield criminal charges

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Staying Connected: Care Management
The intervention combines case management, psychopharmacological and culturally appropriate and individually tailored trauma support activities with evidence-based treatments.A key feature is the provision of a continuous healing relationship by a care management treatment team.The care manager, informed by the Native healer interviews, will provide a culturally appropriate and ongoing helping relationship to each intervention patient in the weeks and months post-injury and will remain in close contact with the trauma survivor subject for 6 months.Together, the care manager and trauma survivor subject will work on a plan to readjust to daily activities. The care management team will also coordinate psychopharmacological interventions for PTSD and related co-morbidities with primary care and or other community providers.
The overarching goal of the Staying Connected intervention is to establish a compassionate and culturally sensitive treatment trajectory that diminishes posttraumatic suffering by reducing symptomatic distress, improving functional recovery, and reducing the risk of injury recurrence. This trajectory begins with surgical treatment and extends through outpatient care and community rehabilitation. The collaborative care intervention fundamentally restructures the delivery of mental health care within trauma care systems by bringing together providers currently working independently to form an interdisciplinary mental health team. Team members work together and in a liaison capacity with other trauma center providers and community practitioners in order to bridge care across service delivery sectors.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Post Traumatic Stress Disorder Symptoms assessed by a PCL score
Tijdsspanne: Six months
Six months

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Depression, Composite International Diagnostic Interview and alcohol abuse/dependence
Tijdsspanne: Six months
Six months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Doug Zatzick, MD, University of Washington

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2009

Primaire voltooiing (Werkelijk)

1 juni 2010

Studie voltooiing (Werkelijk)

1 december 2011

Studieregistratiedata

Eerst ingediend

9 juli 2009

Eerst ingediend dat voldeed aan de QC-criteria

10 juli 2009

Eerst geplaatst (Schatting)

13 juli 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

20 juni 2012

Laatste update ingediend die voldeed aan QC-criteria

19 juni 2012

Laatst geverifieerd

1 juni 2012

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 35970-C
  • P60 MD0005-07

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Staying Connected

3
Abonneren